FDA Approves Belimumab for Children 5-17 with Active Lupus Nephritis

The indication for belimumab (Benlysta) has expanded to include pediatric patients with lupus nephritis (LN) that are receiving standard therapy. The developing company GSK, announced today that the US Food and Drug Administration has approved the treatment.

Previously, the indication only included patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy, and patients 18 years and older with active lupus nephritis receiving standard therapy.

Until now, treatment options for children were mostly limited to non-selective immunosuppressants and corticosteroids. The approved monoclonal antibody serves as a BLyS-specific inhibitor by binding to soluble BLyS without binding directly to B cells. This inhibits the B cells survival and reduces the differentiation of the cells into immunoglobulin-producing plasma.

This decision marks the first approval for pediatric LN, which is associated with increased complications, hospitalizations, and mortality rates in children. Belimumab is also the first and only biologic that's gained approval for the pediatric and adult SLE, LN populations.

“The long-term goal of lupus nephritis management in adults and children is to preserve renal function while minimizing treatment-related toxicities and associated morbidity,” Herson Quinones, VP, Specialty and Pipeline US Medical Affairs, GSK, said in a statement. “This Benlysta approval highlights GSK’s commitment to bring treatment options to children living with lupus nephritis. This is another example of how GSK continues to get ahead of this burdensome disease by focusing on science and being grounded in over a decade of clinical experience.”

Patients with lupus nephritis or systemic lupus erythematosus can experience kidney inflammation as a result of the disease, which affects the small blood vessels that filter wastes in the kidney. If the inflammation escalates to end-stage kidney disease, a transplant or dialysis is required.

“Active lupus nephritis is a potential serious complication in children with lupus, with most cases occurring within the first two years after their initial lupus diagnosis,” Stevan W. Gibson, President and CEO, Lupus Foundation of America said. “This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life.”